The Fifth Pharmaceutical Quality Forum Symposium-
Co-Sponsored by ISPE

Friday 9th June 2006 Yokohama Municipal Education Hall
0830 - 0900 Registration
0900 - 0905 WelcomeCharles Hoiberg ISPE
0905 - 0915 Opening RemarksAkira Kawahara, Director, Evaluation and Licensing Division, MHLW

Session I (John Berridge, Haruhiro Okuda, co-chairs)
Intended Deliverable: Information on latest Q8 thinking and how it can be incorporated into regulatory submissions
09:15 - 09:45ICH Q-8 Update: Fritz Erni -EFPIA (ICH Q8 Rapporteur)
Incorporating Design Space thinking into a submission - authorities' views and case studies
09:45 - 10:15MHLW Reviewer' s viewTamiji Nakanishi (PMDA)
10:15 - 10:45EU' s viewJean-Louis Robert (EU)
10:45 - 11:00Break
11:00 - 11:30FDA' s viewChi-Wan Chen (FDA)
11:30 - 12:00Design Space case study IKazuhiro Ohkouchi(JPMA)
12:00 - 12:30Opportunity and Challenge from the International-based Companies PerspectiveKimiya Okazaki (JPMA)
12:30 - 13:00Questions and Answers
13:00 - 14:00Lunch
Session II (Jean-Louis Robert, Shigeru Matsuki, co-chairs)
Intended Deliverable: greater understanding of the issues, challenges and opportunities for revising and harmonizing a comprehensive QoS(Quality overall Summary) /Quality Gaiyo
14:00 - 14:30Why was revision of the QOS proposed? Key elements from the concept paper     Proposal: Jean-Louis Robert (EU and CTD-Q Rapporteur)
The QOS as a submission and review document. Historical perspectives and future opportunities.
14:30 - 14:45MHLW Reviewer' s ExperienceMayumi Shikano (PMDA)
14:45 - 15:00Canadian ExperienceSultan Ghani (Health Canada)
15:00 - 15:30Japanese Experience-Benefits of Quality GaiyoNobukazu Igoshi (JPMA)
15:30 - 15:45Break
15:45 - 16:15US Regulators' perspectiveMoheb Nasr (FDA)
16:15 - 16:45US Industry perspectiveBob Baum (PhRMA)
16:45 - 17:15EU Industry perspectiveJohn Berridge (EFPIA)
17:15 - 17:45Panel discussion of key elements to be included in the revised QOS
17:45 Closing Remarks Director General of JPMA

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